Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis

Phase 2

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: 0.5% levofloxacin eye drops

• Registration Number: NCT00565123
• Lead Sponsor: Laser Microsurgery Centre, Poland

Brief Summary

The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2006-01
• Status Verified: 2007-11
• Study First Submitted: 2007-11-27
• Study First Submitted QC: 2007-11-28
• Last Update Submitted: 2007-11-28
• Study First Posted: 2007-11-29
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Male and female patients between 18 and 70 years of age
• Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection)
• Patients who have given and signed informed consent
• The ability and willingness to comply with all study procedures

Exclusion Criteria

• Insulin Dependent Diabetes Mellitus (IDDM)
• Patients with keratitis or hordeolum
• Glaucoma
• Sjogren's Syndrom and "Sick Eye's Syndrom".
• Ectropion, entropion;
• Using contact lenses during the study
• Poor visual acuity in the other eye
• Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study;
• Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5)
• Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5)
• Concurrent other eye drops
• All ocular surgeries which were performed less than 6 months before the beginning of the study.
• Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
• History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma.
• Hypersensitivity to fluoroquinolons and benzalkonium chloride;
• Intended or ascertained pregnancy or lactation;
• Participation in a clinical trial within last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	0.5% levofloxacin eye drops	Experimental dosage
Group B	0.5% levofloxacin eye drops	Classical dosage

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint was the clinical cure.	7(+-1) days

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy end point was the microbiological eradication.	7(+-1) days

Trial Locations

Locations (1)

Centrum Mikrochirurgii Oka Laser; 🇵🇱 Warszawa, Mazowieckie, Poland